82 FR 40009 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 162 (August 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 162 (August 23, 2017)
| Page Range | 40009-40009 | |
| FR Document | 2017-17871 |
[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)] [Notices] [Page 40009] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17871] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-N-0804; FDA-2013-N-1163; FDA-2013-N-1393; FDA- 2017-N-0084; FDA-2013-N-0731; FDA-2009-D-0008; FDA-2013-N-0868; FDA- 2013-D-0117; FDA-2016-N-2066; FDA-2017-N-0366] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Table 1--List of Information Collections Approved by OMB ------------------------------------------------------------------------ OMB control Date approval Title of collection No. expires ------------------------------------------------------------------------ Premarket Notification Submission 0910-0120 6/30/2020 510(k), Subpart E...................... Institutional Review Boards............. 0910-0130 6/30/2020 Patent Term Restoration, Due Diligence 0910-0233 6/30/2020 Petitions, Filing, Format, and Content of Petitions........................... Adverse Event Program for Medical 0910-0471 6/30/2020 Devices (Medical Product Safety Network (MedSun)).............................. Eligibility Determination for Donors of 0910-0543 6/30/2020 Human Cells, Tissues, and Cellular and Tissue-Based Products.................. Citizen Petitions and Petitions for Stay 0910-0679 6/30/2020 of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.................................... Guidance for Industry: Use of 0910-0681 6/30/2020 Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion.... Providing Information About Pediatric 0910-0762 6/30/2020 Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act........................... Certification of Identity for Freedom of 0910-0832 6/30/2020 Information Act and Privacy Act Requests............................... FDA Advisory Committee Membership 0910-0833 6/30/2020 Nominations............................ ------------------------------------------------------------------------ Dated: August 18, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-17871 Filed 8-22-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 40009
received no comments on the draft IV. Electronic Access ACTION: Notice.
guidance. The guidance announced in
Persons with access to the internet SUMMARY: The Food and Drug
this notice finalizes the draft guidance
may obtain the guidance at either Administration (FDA) is publishing a
dated June 2015.
https://www.fda.gov/AnimalVeterinary/ list of information collections that have
II. Significance of Guidance GuidanceComplianceEnforcement/ been approved by the Office of
GuidanceforIndustry/default.htm or Management and Budget (OMB) under
This level 1 guidance is being issued
https://www.regulations.gov. the Paperwork Reduction Act of 1995.
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). Dated: August 18, 2017. FOR FURTHER INFORMATION CONTACT: Ila
The guidance represents the current Leslie Kux, S. Mizrachi, FDA PRA Staff, Office of
thinking of FDA on oncology drugs for Associate Commissioner for Policy. Operations, Food and Drug
companion animals. It does not [FR Doc. 2017–17855 Filed 8–22–17; 8:45 am] Administration, Three White Flint
establish any rights for any person and BILLING CODE 4164–01–P
North, 11601 Landsdown St., North
is not binding on FDA or the public. Bethesda, MD 20852, 301–796–7726,
You can use an alternative approach if PRAStaff@fda.hhs.gov.
it satisfies the requirements of the DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: The
applicable statutes and regulations. This HUMAN SERVICES following is a list of FDA information
guidance is not subject to Executive collections recently approved by OMB
Order 12866. Food and Drug Administration under section 3507 of the Paperwork
III. Paperwork Reduction Act of 1995 Reduction Act of 1995 (44 U.S.C. 3507).
[Docket Nos. FDA–2013–N–0804; FDA– The OMB control number and
This guidance refers to previously 2013–N–1163; FDA–2013–N–1393; FDA– expiration date of OMB approval for
approved collections of information 2017–N–0084; FDA–2013–N–0731; FDA– each information collection are shown
found in FDA regulations. These 2009–D–0008; FDA–2013–N–0868; FDA– in table 1. Copies of the supporting
2013–D–0117; FDA–2016–N–2066; FDA–
collections of information are subject to statements for the information
2017–N–0366]
review by the Office of Management and collections are available on the internet
Budget (OMB) under the Paperwork Agency Information Collection at https://www.reginfo.gov/public/do/
Reduction Act of 1995 (44 U.S.C. 3501– Activities; Announcement of Office of PRAMain. An Agency may not conduct
3520). The collections of information in Management and Budget Approvals or sponsor, and a person is not required
21 CFR 514.1 and 514.8 have been to respond to, a collection of
approved under OMB control number AGENCY: Food and Drug Administration, information unless it displays a
0910–0032. HHS. currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires
Premarket Notification Submission 510(k), Subpart E ............................................................................................ 0910–0120 6/30/2020
Institutional Review Boards ..................................................................................................................................... 0910–0130 6/30/2020
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions ................................ 0910–0233 6/30/2020
Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)) ................................. 0910–0471 6/30/2020
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products ............. 0910–0543 6/30/2020
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act ........................................................................................................................................................ 0910–0679 6/30/2020
Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi In-
fection in Whole Blood and Blood Components Intended for Transfusion ......................................................... 0910–0681 6/30/2020
Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food,
Drug, and Cosmetic Act ....................................................................................................................................... 0910–0762 6/30/2020
Certification of Identity for Freedom of Information Act and Privacy Act Requests ............................................... 0910–0832 6/30/2020
FDA Advisory Committee Membership Nominations .............................................................................................. 0910–0833 6/30/2020
Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17871 Filed 8–22–17; 8:45 am]
BILLING CODE 4164–01–P
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Document Created: 2017-08-22 23:52:07
Document Modified: 2017-08-22 23:52:07
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Ila S. Mizrachi, FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 40009 |
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